AccessGUDID - DEVICE: HARVEST® BMAC® (05020583514232)

GUDID

Device Identifier (DI) Information

Brand Name: HARVEST® BMAC®
Version or Model: 51423
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TERUMO BCT, INC.

Primary DI Number: 05020583514232
Issuing Agency: GS1
Commercial Distribution End Date: November 15, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 801679200 *Terms of Use

Device Description: Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-120-01 Procedure Pack

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47153	Haematological concentrate system preparation kit, bone marrow concentration	A collection of sterile devices typically used at the point-of-care for the rapid preparation of autologous bone marrow aspirate concentrate (BMAC) from bone marrow aspirate. The kit components, with the bone marrow aspirate, are directly placed in a dedicated centrifuge that separates and concentrates the bone marrow. The cellular BMAC preparations are typically applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. The kit may include specimen drawing devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQC	CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 476c798c-89da-4dfa-9a29-9d7247b51d8c
Public Version Date: February 08, 2024
Public Version Number: 12
DI Record Publish Date: September 15, 2016